Abstract: This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and a non-ionic surfactant.

Abstract: The disclosure provides a method of preparing an immunologically-active adjuvant-bound freeze dried vaccine composition. A specific embodiment provides a stable vaccine composition comprising an aluminum-salt adjuvant, a recombinant Clostridium botulinum neurotoxin protein and a glass-forming agent. These vaccine compositions are useful in the treatment of humans and other animals at risk of infection from Clostridium botulinum neurotoxin.

Abstract: This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and a non-ionic surfactant.

Abstract: The present invention provides methods of optimizing certain stable liquid formulations of antibodies that immunospecifically bind to antigens of interest. Such formulations are suitable for parenteral administration to a subject, and exhibit increased stability, low to undetectable levels of aggregation, low to undetectable levels of antibody fragmentation/degradation, and very little to no loss of the biological activities of the antibodies, even during long periods of storage. The methods of the invention provide formulations that offer multiple advantages over formulations produced by non-optimized methods, including less stringent or more readily available transportation and storage conditions, less frequent dosing, and/or smaller dosage amounts in the therapeutic, prophylactic and diagnostic uses of such formulations. The invention further provides methods of identifying antibodies exhibiting certain phase behaviors such that the antibodies can be formulated by the methods of the invention.

Abstract: The present invention provides methods and devices for producing particles with an average diameter less than about 15 ?m using the precipitation with compressed fluid-antisolvent (PCA) process and the carbon-dioxide assisted nebulization with a bubble dryer (CAN-BD) process. In the methods and nozzles of the invention, at least one jet of supercritical or near-supercritical fluid and at least one jet of solution interact to mix the supercritical or near-supercritical fluid and the solution within a chamber. The solution contains at least one solvent and at least one solute. At least one of the jets is a swirling jet. To form particles, the solvent and supercritical or near-supercritical fluid are then injected into a PCA or a CAN-BD process chamber. The degree of mixing depends in part on the power input into the mixing chamber. Power inputs of about 6.5×109 W/m3 enhance the degree of mixing and allow production of nanoscale particles with the PCA process.

Abstract: The present disclosure provides an effective method for the refolding of denatured proteins in solution so that properly folded, biologically active protein in solution is recovered in high yield. The refolding takes place at pressures between about 0.25 kbar to about 3.5 kbar, advantageously at about 1.5 kbar to about 3 kbar. Typically a chaotropic agent is present at a concentration which is not effective for denaturing protein at atmospheric pressure, and optionally, oxidation-reduction reagents can be incorporated in the refolding solution so that native intramolecular disulfide bonds can be formed where that is desired. The method is applicable to substantially all proteins, especially after solubilization and/or denaturation of insoluble protein aggregates, inclusion bodies, or abnormal oligomeric (soluble) aggregates.

Abstract: The invention provides compositions containing hydroxyethyl starch and polypeptides, including therapeutic polypeptides such as interleukin-11, that provide for enhanced stability of the polypeptide following storage at room temperature or elevated temperatures.

Abstract: The invention provides methods of modifying the crystal habit of a compound without altering the crystal structure of the compound through a controlled precipitation technique in the presence of a crystal growth inhibitor as well as the crystallized compounds formed by these methods. Using these methods, the crystal habit of the compound may be modified from acicular to bipyramidal. The modification in crystal habit is attributable to a preferential adsorption mechanism of the crystal growth inhibitor to a fast growing crystal face of the compound. Powder flow properties of the crystallized product are significantly enhanced with the habit modification. This selective crystal habit modification using a crystal growth inhibitor provides a strategy to circumvent the manufacturing difficulties associated with acicular crystal habits, and may increase the manufacturing capability of supercritical fluid based crystallization and precipitation technologies.

Abstract: Methods of forming crosslinked polymer particles in situ from polymer precursors such as monomers or oligomers, comprising exposing a composition comprising at least one polymer precursor, a solvent or solvent mixture, and an antisolvent or antisolvent mixture to photoradiation under conditions whereby particles are formed are provided. The polymer precursor may be photosensitive, or a separate polymerization initiator may be used. In a preferred embodiment, the polymer precursor is insoluble in the antisolvent or antisolvent mixture and the solvent or solvent mixture is soluble in the antisolvent or antisolvent mixture at the concentrations used. Crosslinked polymer particles and crosslinked polymer particles comprising a polymer and a bioactive material are also provided. The polymer may be erodable, and the polymer particles formed may be used in a variety of applications, including controlled release of bioactive materials such as drugs.

Abstract: The present invention provides methods and devices for producing particles with an average diameter less than about 15 ?m using the precipitation with compressed fluid-antisolvent (PCA) process and the carbon-dioxide assisted nebulization with a bubble dryer (CAN-BD) process. In the methods and nozzles of the invention, at least one jet of supercritical or near-supercritical fluid and at least one jet of solution interact to mix the supercritical or near-supercritical fluid and the solution within a chamber. The solution contains at least one solvent and at least one solute. At least one of the jets is a swirling jet. To form particles, the solvent and supercritical or near-supercritical fluid are then injected into a PCA or a CAN-BD process chamber. The degree of mixing depends in part on the power input into the mixing chamber. Power inputs of about 6.5×109 W/m3 enhance the degree of mixing and allow production of nanoscale particles with the PCA process.

Abstract: Methods of forming crosslinked polymer particles in situ from polymer precursors such as monomers or oligomers, comprising exposing a composition comprising at least one polymer precursor, a solvent or solvent mixture, and an antisolvent or antisolvent mixture to photoradiation under conditions whereby particles are formed are provided. The polymer precursor may be photosensitive, or a separate polymerization initiator may be used. In a preferred embodiment, the polymer precursor is insoluble in the antisolvent or antisolvent mixture and the solvent or solvent mixture is soluble in the antisolvent or antisolvent mixture at the concentrations used. Crosslinked polymer particles and crosslinked polymer particles comprising a polymer and a bioactive material are also provided. The polymer may be erodable, and the polymer particles formed may be used in a variety of applications, including controlled release of bioactive materials such as drugs.

Abstract: Methods of forming crosslinked polymer particles in situ from polymer precursors such as monomers or oligomers, comprising exposing a composition comprising at least one polymer precursor, a solvent or solvent mixture, and an antisolvent or antisolvent mixture to photoradiation under conditions whereby particles are formed are provided. The polymer precursor may be photosensitive, or a separate polymerization initiator may be used. In a preferred embodiment, the polymer precursor is insoluble in the antisolvent or antisolvent mixture and the solvent or solvent mixture is soluble in the antisolvent or antisolvent mixture at the concentrations used. Crosslinked polymer particles and crosslinked polymer particles comprising a polymer and a bioactive material are also provided. The polymer may be erodable, and the polymer particles formed may be used in a variety of applications, including controlled release of bioactive materials such as drugs.

Abstract: Methods of forming polymer particles in situ from polymer precursors such as monomers or oligomers, comprising exposing a composition comprising at least one polymer precursor, a solvent or solvent mixture, and an antisolvent or antisolvent mixture to photoradiation under conditions whereby particles are formed are provided. The polymer precursor may be photosensitive, or a separate polymerization initiator may be used. In a preferred embodiment, the polymer precursor is insoluble in the antisolvent or antisolvent mixture and the solvent or solvent mixture is soluble in the antisolvent or antisolvent mixture at the concentrations used. Polymer particles comprising a polymer and a bioactive material are also provided. The polymer may be erodable, and the polymer particles formed may be used in a variety of applications, including controlled release of bioactive materials such as drugs.

Abstract: A process for preparing high density polyethylene in the gas phase comprising contacting a mixture comprising ethylene and one or more alpha-olefins with the supported reaction product of a bis-hydrocarbylsilyl chromate and a hydrocarbylaluminum compound or a hydrocarbyl boron compound in a fluidized bed reactor having a recycle gas line, under particularly defined polymerization conditions, including, but not limited to, the following provisos:(i) oxygen and/or another catalyst poison is introduced into the reactor in the range of about 0.005 to about 0.5 part by volume of catalyst poison per million parts by volume of ethylene; and(ii) a relatively low boiling inert hydrocarbon is introduced into the recycle gas line in an amount sufficient to raise the dew point of the recycle gas, which is comprised of alpha-olefins and other reactor gases, and the recycle gas is partially condensed and recycled to the reactor where it promotes cooling by evaporation.

Abstract: A method is provided for producing a product by enzyme-catalyzed reaction using supercritical fluid as a solvent. Improved reaction times, conversion efficiencies and/or other efficiencies (such as improved ease of product recovery) are obtained.